
Best Answer TimG, Yesterday, 07:49 PM
Afternoon Jean. You will want to discuss with your QandFS group and try to determine 'WHY' you missed these issues (or why you found them, but they didn't get addressed). Your CA should address WHY (root cause) you missed these items the auditor noted and then put something in place you feel will keep that from happening in the future. Rather it be frequency of inspections, more specific wording on your existing inspections, etc.
I can't in good conscience spoon feed you the C/A or abatement measures, but I'd personally try to address these by making sure my internal GMP inspection or facility inspection is updated to include wording so the person doing the inspection is instructed to look for these and similar issues.
